BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 42MM CONST HUM LINER +2.5

    MDR report key: 21797991 · Received April 8, 2025

    Report

    Report Number
    1038671-2025-01771
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 19, 2025
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 320-15-05 - EQ REV LOCKING SCREW: A072835, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: A080460, 300-01-13 - EQUINOXE, HUM STEM PRIMARY, PRESS FIT 13MM: A000297, 320-15-01 - EQ REV GLENOID PLATE: A004485, 320-20-18 - EQ REV COMPRESS SCR LCK CAP KIT, 4.5 X 18MM: S348816, 320-20-18 - EQ REV COMPRESS SCR LCK CAP KIT, 4.5 X 18MM: S360683, 320-20-30 - EQ REV COMPRESS SCR LCK CAP KIT, 4.5 X 30MM: S342770, 320-20-38 - EQ REV COMPRESS SCRE LCK CAP KIT, 4.5 X 38MM: S117023. H3: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY LEADING TO SUBSEQUENT METAL-ON-METAL ARTICULATION BETWEEN UNINTENDED COMPONENTS, AND DAMAGE TO THE HUMERAL LINER. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT, AN UNREPORTED TRAUMATIC EVENT, INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), OR A COMBINATION OF THE ABOVE TO THE DISASSEMBLY OF THE HUMERAL LINER CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 2 YEARS 7 MONTHS POST INITIAL OPERATION. THE PATIENT LIKELY DISSOCIATED THE HUMERAL LINER FROM THE TRAY WHILE LIFTING A HEAVY OBJECT AT WORK ABOVE HIS HEAD. PATIENT STATES THIS OCCURRED 6-7 MONTH PRIOR TO REVISION SURGERY. THERE WAS SIGNIFICANT CONTACT BETWEEN THE METAL HUMERAL TRAY AND THE GLENOSPHERE IN THE INTERVENING TIME. THIS RESULTED IN SEVERE METALLOSIS IN THE GLENOHUMERAL JOINT SPACE AND SURROUNDING SOFT TISSUE. SURGEON PERFORMED AN EXTENSIVE DEBRIDEMENT OF THE JOINT SPACE AND REPLACED SOME INSITU COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721403 145-DEG PE 42MM CONST HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization SEE H11